510(k) · Cleared

Cleared

STC Opiates Micro-Plate Eia (Orasure Application)

K981341510(k) TraditionalCleared May 22, 199839-day reviewClass II21 CFR 862.3650

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

OraSure Technologies, Inc. · DJG Enzyme Immunoassay, Opiates

Cleared on May 22, 1998 as substantially equivalent to K924446 (Solarcare Technologies Corp,Inc., 1992) after a 39-day review. Its family tree reaches back 1 generation to 1992. 20 later devices descend from it.

Decided: May 22, 1998
Review: 39 days
Class: Class II
Product code: DJG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K924446 (1992). 20 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK924446 Micro-Plate Opiates AssaySolarcare Technologies Corp,Inc. · 1992
This deviceK981341 STC Opiates Micro-Plate Eia (Orasure Application)OraSure Technologies, Inc. · 1998
Descendant · cites it directly · 6 of its ownK103227 Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012
Descendant · cites it directly · 6 of its ownK050988 Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and…Lin-Zhi International, Inc. · 2006
Descendant · 2 generations on · 3 of its ownK171403 OralTox Oral Fluid Drug TestPremier Biotech, Inc. · 2018
Descendant · cites it directly · 3 of its ownK101754 Thermo Scientific Cedia Opiate Oft AssayMicrogenics Corp. · 2011
Descendant · 2 generations on · 3 of its ownK062242 Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay…Lin-Zhi International, Inc. · 2006

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2002high 4 (2014) · low 0 (2004)2026

Most influential descendants

Showing 5 of 20 · See all

K103227Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012 · cites it directly6descendants
K050988Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and ControlsLin-Zhi International, Inc. · 2006 · cites it directly6descendants
K171403OralTox Oral Fluid Drug TestPremier Biotech, Inc. · 2018 · 2 generations on3descendants
K101754Thermo Scientific Cedia Opiate Oft AssayMicrogenics Corp. · 2011 · cites it directly3descendants
K062242Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and ControlsLin-Zhi International, Inc. · 2006 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924446	Micro-Plate Opiates Assay	Solarcare Technologies Corp,Inc.	1992	—
0 (this device)	K981341	STC Opiates Micro-Plate Eia (Orasure Application)	OraSure Technologies, Inc.	1998	—
+1	K103227	Oratect Oral Fluid Drug Screen Devices	Branan Medical Corporation	2012	—
+1	K050988	Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls	Lin-Zhi International, Inc.	2006	—
+2	K171403	OralTox Oral Fluid Drug Test	Premier Biotech, Inc.	2018	—
+1	K101754	Thermo Scientific Cedia Opiate Oft Assay	Microgenics Corp.	2011	—
+2	K062242	Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and…	Lin-Zhi International, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2006	3	0
2011	1	0
2012	1	0
2013	1	0
2014	4	0
2015	1	0
2018	2	0
2021	2	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K981341, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DJG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DJG device

#1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K924446	Micro-Plate Opiates Assay Summary page 1 …) Usual Name: Opiates EIA Classification Name: Enzyme Immunoassay, Opiates 3. Device to Which Substantial Equivalence Is Claimed: STC Opiates Micro-Plate EIA (Urine); K924446 4. Description of Device: Principle of the Assay The STC Opiates EIA is a competitive micro-plate immunoassay for the detecti…	Solarcare Technologies Corp,Inc.	1992	—

What descends from it? (20)

See all 20

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K103227	Oratect Oral Fluid Drug Screen Devices	Branan Medical Corporation	2012	6
K050988	Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls	Lin-Zhi International, Inc.	2006	6
K101754	Thermo Scientific Cedia Opiate Oft Assay	Microgenics Corp.	2011	3
K030234	Cozart Eia Cocaine Oral Fliud Kit	Cozart Bioscience, Ltd.	2003	0
K020371	Uplink Test System	OraSure Technologies, Inc.	2002	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K103227 (Branan Medical Corporation, 2012) has gone furthest, with 6 descendants of its own.

How does its category compare?

All DJG devices

DJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DJG

3in 2025

2007high 12 (2015) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DJG

31in 2025

2007high 422 (2021) · low 30 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DJG

2in 2025

2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DJG

1in 2025

2007high 4 (2011) · low 0 (2007)2025

MAUDE reports naming product code DJG, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	0
2008	2	—	0	0
2009	2	—	0	0
2010	6	187	0	0
2011	6	233	1	4
2012	5	95	0	1
2013	5	60	0	4
2014	9	62	0	0
2015	12	141	0	3
2016	2	—	0	2
2017	4	101	0	1
2018	5	134	0	1
2019	3	235	1	0
2020	5	30	0	0
2021	3	422	0	2
2022	2	—	0	1
2023	10	140	0	0
2024	5	150	0	3
2025	3	31	2	1
2026	3	157	0	—

What is it indicated for?

The STC Opiates Micro-Plate EIA is intended for use in the qualitative determination of opiates in oral fluid collected with the OraSure® Oral Collection Device. For In Vitro Diagnostic Use.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K981341 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981341: STC Opiates Micro-Plate Eia (Orasure Application).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981341

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026